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LITTLE ROCK, AR– Idenix Pharmaceuticals, a global biopharmaceutical company that works for the discovery and improvement of medications for human viral diseases treatment, announced that the U.S. Food and Drug Administration (FDA) has placed a partial clinical hold on IDX184, the nucleotide polymerase inhibitor that is being developed by Idenix for the treatment of hepatitis C virus (HCV).
According to the FDA, it has to further review the safety of IDX184, which is why it has been put on hold.
This was because of a recent severe cardiac-related effect observed on the nucleotide polymerase inhibitor for HCV treatment developed by a competitor. The FDA has asked the Company for more data regarding patients who have received IDX184 treatment.
In the ongoing clinical trial of IDX184, combined with ribavirin and pegylated interferon, no evidence of cardiotoxicity has been found yet in patients who were given IDX184 with ribavirin other than what is observed with ribavirin alone.
Also called tribavirin, ribavirin is an anti-viral drug used for hepatitis C, RSV infection, and viral hemorrhagic fever treatment. To date, no patient has received IDX184 alone worldwide.
Idenix assures the safety of every patient and is committed to complying with the FDA’s requests. Continuous discussions with the FDA representatives will be pushed after submitting the data requested by the FDA.
Headquartered in Little Rock, Arkansas, Idenix Pharmaceuticals is a global biopharmaceutical company for the discovery and development of medications for human viral diseases treatment.
For nearly 20 years, the company has invested in research and development as well as innovative technologies to come up with pharmaceutical solutions that work. Currently, the company focuses on the treatment of hepatitis C infection patients. For more information about Idenix, please visit www.idenix.com.
IDX184 is a new nucleotide prodrug of 2′-methyl guanosine that targets the liver to treat patients with hepatitis C virus.
It includes Idenix’s proprietary liver-targeting technology that provides the supply of nucleoside monophosphate to the liver, which forms nucleoside triphosphate in high levels. This can maximize drug efficacy and restrict systemic side effects as low as the dosage is low and given once daily.
In the ongoing clinical trial of IDX184 combined with ribavirin, 100% of 31 patients in the 100mg arm who completed a month’s worth of ribavirin treatment and achieved a prolonged virologic response were able to show a sustained virologic response a month after the treatment.
A third-party data corroborates with Idenix’s findings. A safety monitoring board evaluated the safety figures for this study. The board confirmed that the side effects associated with the combination of IDX184 and ribavirin are the same as that of ribavirin alone.
A partial clinical hold refers to the temporary delay of only a portion of the clinical work under the new drug application. Under this FDA directive, a specific protocol is not allowed to proceed.
But other protocols can be performed. This means that Idenix is not allowed by the FDA to enroll patients into supplementary clinical trials until the FDA agrees on the next clinical trial design.
Athletes and bodybuilders looking to gain more muscle mass and be in better shape have a lot of options in the market today, including anabolic products.
Here is an impartial look on one of the widely recognized anabolic supplements today: D-Anabol 25.
D-Anabol 25 is a legal steroid made for men who wantto build their muscle mass within a short period. Aside from muscle gains, this supplement also enhances muscle pumps and boosts strength.
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Unlike true anabolic steroids, D-Anabol 25 does not lead to harmful side effects to the user. This makes it an ideal alternative to the likes of Dianabol.
This bodybuilding supplement helps build lean muscle mass in the following ways:
In essence, D-Anabol 25 offers all the muscle-building benefits of Dianabol minus the side effects. It is also more potent than the conventional testosterone supplements that bodybuilders use.
The anabolic product can be used either as a standalone supplement or as part of a stack when improving one’s performance in resistance and cardio workouts. For the best results, the user should follow the manufacturer’s instructions on consuming this product.
The correct intake is one capsule thrice a day, taken with 8 oz. of water. Each intake should be spaced out evenly. A bottle has 90 capsules, so it should last for 30 days. After that cycle, it is best that you give your body a break for about a week and a half before you consume another bottle of D-Anabol 25.
D-Anabol 25, being a versatile bodybuilding supplement, is a great choice for the following individuals:
Consumers who are considering to switch to this muscle-gaining supplement are advised to do research to ensure not just the effectiveness of the product but also its safety according to their health condition.
Today, one of the most common life-threatening viruses in the world is Hepatitis C. As a potential killer, the deadly virus has the power to damage an individual’s liver function. The liver plays a vital role in how it filters toxins out of the body. However, someone who has hepatitis C and abuses drugs puts their health in grave risk of danger.
Hepatitis means the inflammation of the liver. The true form of the virus will spread once the virus becomes active. As hepatitis C enters the body, the virus will enter through the bloodstream and travel to the liver.During the first stage, the hepatitis virus will live inside the liver and thrive.
According to research at the San Diego State University Foundation, there are an estimated number of 4 million people in the U.S. exposed to the virus.
This virus can be contracted when someone drinks or eats something that is contaminated by the blood or tool of someone who is infected by the virus. However Hepatitis A does not develop into a serious condition as it would with the B and C virus.
If you use a syringe to inject drugs such as cocaine, LSD, or heroine, it only takes one event to contract the virus. This means anyone who experiments with an infected syringe can be exposed to the virus.
In fact, over 60% of hepatitis C cases were a result of injection drug use. The infection occurs within the first year of the injection for more than half of hepatitis C cases. This is partly due to how the equipment is used as large groups share the drug solution with one set of equipment. As a result, the transmission quickly spreads from one person to another.
More treatments include replacing injections with pills and reducing the side effects in treatment in as little as eight weeks. However, the treatment must be used with a set of combination of ribavirin and interferon to help control the virus and stabilize the spread through the liver.
As a result, more companies like Idenix are using a lead method of treatment called IDX21437 is noted as one of the most potential drugs for treating hepatitis C.
Antiviral medications are prescribed when the virus is rapidly growing in the body. During the case if a patient consumes large amount of alcohol, a physician may prevent the patient from receiving treatment. This is due to the anti-effect of the medication that the alcohol cancels out.
Just as with any virus, hepatitis can stay in the body for years before it can be determined and affect the functions of the liver. If you have used syringe injections in the past and find yourself suffering from flu-like symptoms, be sure to consult with your physician and discuss the potential of the hepatitis C virus.
Looking for more information on the pharmaceutical industry? In this guide, we will provide some essential resources to help you gather more information and knowledge.
Check out these top 5 resources to gain insight on the pharmaceutical industry.
American Society of Health-System Pharmacists – https://www.ashp.org/
With over 40,000 members of ASHP, you will discover members that include pharmacists, students, and techs on a solid platform with an effort to improve medication and enhance patient safety. The mission of ASHP is to help others achieve optimal health by supporting and raising awareness to the practice of pharmacists in all health settings.
Centers for Disease Control and Prevention – https://www.cdc.gov/
CDC strives to provide solid protection and awareness in protecting the health of America and across the globe. CDC fights to help support citizens and communities in fighting the outbreak of disease and increase the health security of our nation. CDC provides health information that protects the nation against dangerous threats against health and responds immediately to attacks.
Drug Information Association – http://www.diaglobal.org/
For over 50 years, the DIA has continued to serve as a non-profit association and resource that provides extended opportunities for the discussion of medical innovation. DIA aims to improve health by fostering innovation, providing valuable forums to discuss current issues, deliver learning experiences, and offer a respected environment to build, grow, and continue relationships with those who share the values of DIA.
Health Industry Distributors Association – http://www.hida.org/
The Health Industry Distributors Association seeks to provide leadership and a broad range of resources to help companies perform profitably within today’s healthcare. Members offer services that are used to promote efficiency offer the nation’s hospitals, practices, nursing homes and other health care institutions.
Pharmacy Practice News – http://www.pharmacypracticenews.com/
The Pharmacy Practice News provides pharmacists with relevant and up to date information on how to improve their clinical practice. The website provides regular features that include lessons, new FDA approvals on drugs, and reviews.
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Looking to get on the right track of the pharmaceutical industry? The best way to stay ahead of the market is through conferences and seminars. Not only will they help you stay in the know of it all but also keep you building strong networks.
Here are the top 4 pharmaceutical conferences to attend in 2017.
9th International Conference and Exhibition on Pharmacovigilance & Drug Safety – 7/17 – 18, 2017
In accordance with the advanced regulatory compliance in Pharma operations and innovation, you will need with speakers and experts to discuss the current issues in the industry. Speakers will discuss the current analysis of off-label use, under reporting of adverse drug reactions, data efficiency, and how the Brexit will affect the pharmaceutical industry.
5th International Conference on Pharmacognosy, Phytochemistry & Natural Products – 7/24 – 25, 2017
The event will discuss the latest trends of strategies in effective medicine and natural products for health use. Attendees will great new perspectives and further knowledge in the field of science. The conference also provides a solid platform for pharmacists to meet and discuss their views through their exhibitions and workshops.
Thirteenth Annual International Conference and Exhibition on Nanomedicine and Pharmaceutical Nanotechnology – 7/24- 25, 2017
One of the most highly notable conferences in the world is the NanoMed conference were speakers will discuss new therapies, advanced drug delivery systems, and nanomaterials for drug delivery and imaging. Speakers will also discuss nanotechnology and the ability to understand materials at the tiniest scales.
Third Annual World Congress and Exhibition on Antibiotics and Antibiotic Resistance –7/31 – 8/1, 2017
The Antibiotics conference aims to gather the top speakers and attendees from universities across the globe to discuss various aspects of antibiotics. The two-day conference invites researchers, drug manufacturers, professionals and other health care experts to present their opinions and ideas in the field of antibiotics.
Is there any other major pharmaceutical conference not listed that we may have missed? Comment below and let us know!
Interested in following the leading trends from experts in the industry? In this guide, you will find some of the market’s top trends and falls that will help you gain further insight into the next trends to come.
Here are the top 5 trends in the pharmaceutical industry 2017.
Today, more pharmaceutical companies are looking to work alone and go beyond of drug. With technology that helps track patient compliance and monitoring, this helps to give companies a competitive edge without the need for partnerships. In fact, there are more non-traditional deals now than ever as mobile and telecom companies are helping to make pharmaceutical companies move past the basic pill and more into comprehensive medical products that can help diagnose, monitor and more potential applications.
As 2016 was all about the conspiracy of drug prices, 2017 will only continue the trend even further. There is a clear message that the annual or quarterly drug price will increase to fuel sales growth even more. With President Trump’s plan to stiffen the challenges, the need of volume growth will continue to increase. This means that pharmaceutical manufacturers must increase their volume of growth to continue sustainable revenue.
As the baby boomer generation continues to grow older, the Alzheimer’s disease is assumed to account for as much as 25% of Medicare by 2040. With the increase in spending, more pharmaceutical companies are on the run for an optimal treatment and prevention to the disease. In fact, billions of dollars have already been invested in targeting antibody medication.
According to Forbes, pharma companies and biotech are developing drugs based on the research of bacterial composition in the gut and how it affects the mood. This will not only open up new methods of treating depression and other related mental illnesses but also brain disorders.
Currently, biosimilar drugs are presenting an affordable option to the consumer and a potential hit for manufacturing companies. These biological products are also continuing to increase in demand as the drug was approved in the U.S. in 2015.
Today, there is over 700 biosimilar approved to be used by 2020.
What are your thoughts on these top trends? Comment below and let us know what you think!